Drugs Tested on Children Without Consent

The Law Of... getting medical consent

National Archive files have revealed that a North Yorkshire Approved School sanctioned the use of experimental drugs on children during the 1960s, without the knowledge or consent of the participants or their parents.

Geoffrey Simpson-Scott, a Partner with Simpson Millar specialising in Medical Negligence, discusses the ethics of this story and the context of the time in which it happened.

Although it took place in 1967, by modern standards it seems unconscionable that drug trials on children could occur without the approval of their parents. However, when judged against the ethical principles of the day, we can start to understand how this was allowed to happen.

The standards were very much different at this time. The 1960s was a period when the ethical rules the medical profession now adheres to were in their infancy, meaning there was still an emphasis on paternalism, with doctors having a greater leeway when it came to determining what was in the patient's best interests.

Best Interests

It is no longer acceptable for doctors to impose their view of what is best. Responsible clinicians should now offer guidance and answer questions so that a patient is fully conversant with what their treatment involves, as well as any consequences or adverse effects it might have.

Likewise, the best interests of a child are now the overriding concern when it comes to recommending medical care. The law recognises that a 15 year old is often able to make an informed choice of their own volition and 16-18 year olds being treated as adults when making medical decisions. For younger children the consent falls to somebody with 'parental responsibility', such as the mother or father, or a legal guardian.

Accordingly, the absence of a parent or guardian does not give either the doctor or the State the authority to make a decision unilaterally, as was the case at the Richmond Hill Approved School in 1967.

Consent is Key

Geoffrey Simpson-Scott comments:

"Consent is key when it comes to prescribing treatment, with the autonomy and best interest of the patient, young or old, being at the heart of everything the medical profession now does. When this is called into question, it is for the court to determine whether sufficient information was provided, allowing the patient to make an informed decision, as opposed to undertaking what is simply standard medical practice in their situation."

"Where there has been no reasonable attempt to obtain a patient's consent, the doctor or medical authority in question can find themselves ruled to have caused a deliberate injury (a battery). It is also often necessary, however, to prove that an injury was caused by the drug or treatment in question."

"In cases where there is a dispute between the parents of a child or an adolescent patient and a clinical team over treatment, the court is guided, again, by what is in the child's best interest, which, in certain cases, overrides a lack of consent from the parent or child."

"What the release of the file regarding the Richmond Hill Approved School demonstrates is how far we've come since then. Consent aside, the level of information given to the boys back then would've been far less than is required nowadays. Whether the tests resulted in any adverse effects is unknown, although the drug had been approved for use on humans, so was not itself inherently dangerous."

"Another question hanging over these trials is whether – despite Home Office approval to go ahead – they complied with the principles of the European Convention on Human Rights (ECHR), which was ratified in the UK in 1951. This could play a key role in any legal proceedings that arise following this recent disclosure."

"It is unclear whether any modern court would approve of what happened in 1967 applying the standards that were then in place, which is why it's important that incidents like these are out in the open and those affected are able to seek careful advice and legal redress, ensuring it never happens again."

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